Notice2025-23707
Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
December 23, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act." This guidance provides recommendations for industry and review staff on the formal dispute resolution (FDR) and administrative hearings procedures for resolving scientific and/or medical disputes between the Center for Drug Evaluation and Research (CDER) and requestors and sponsors of drugs that will be subject to a final administrative order under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ("Final Order"). This guidance finalizes the draft guidance of the same title issued on June 23, 2023.
Full Text
<html>
<head>
<title>Federal Register, Volume 90 Issue 244 (Tuesday, December 23, 2025)</title>
</head>
<body><pre>
[Federal Register Volume 90, Number 244 (Tuesday, December 23, 2025)]
[Notices]
[Pages 60104-60106]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-23707]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2204]
Formal Dispute Resolution and Administrative Hearings of Final
Administrative Orders Under Section 505G of the Federal Food, Drug, and
Cosmetic Act; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``Formal
Dispute Resolution and Administrative Hearings of Final Administrative
Orders Under Section 505G of the Federal Food, Drug, and Cosmetic
Act.'' This guidance provides recommendations for industry and review
staff on the formal dispute resolution (FDR) and administrative
hearings procedures for resolving scientific and/or medical disputes
between the Center for Drug Evaluation and Research (CDER) and
requestors and sponsors of drugs that will be subject to a final
administrative
[[Page 60105]]
order under section 505G of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (``Final Order''). This guidance finalizes the draft
guidance of the same title issued on June 23, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on December 23, 2025.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-2204 for ``Formal Dispute Resolution and Administrative
Hearings of Final Administrative Orders Under Section 505G of the
Federal Food, Drug, and Cosmetic Act.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Suzanne Strayhorn, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, Rm. 6317, Silver Spring, MD 20993, 240-
402-4247.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Formal Dispute Resolution and Administrative Hearings of
Final Administrative Orders Under Section 505G of the Federal Food,
Drug, and Cosmetic Act.'' This guidance provides recommendations for
industry and review staff on the FDR and administrative hearings
procedures for resolving scientific and/or medical disputes between
CDER and requestors and sponsors of drugs that will be subject to a
Final Order under section 505G of the FD&C Act (21 U.S.C. 355h).
Section 505G of the FD&C Act was added by the Coronavirus Aid,
Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136), which
was enacted on March 27, 2020. After FDA issues a Final Order in
accordance with section 505G(b)(2) of the FD&C Act, FDA must afford
eligible requestors or sponsors the opportunity for FDR and hearings on
disputes over the Final Order. This guidance describes the FDR
procedures for eligible requestors or sponsors that wish to appeal a
scientific and/or medical issue related to a Final Order. This guidance
also outlines the procedures for an administrative hearing related to a
Final Order. Finally, as required by section 505G(l)(4) of the FD&C
Act, this guidance describes the procedures for consolidated
proceedings for FDR and hearings to resolve the scientific and/or
medical disputes.
FDA agreed to specific performance goals and procedures described
in the document ``Over-the-Counter Monograph User Fee Program
Performance Goals and Procedures--Fiscal Years 2018-2022,'' commonly
referred to as the OMUFA commitment letter (the document can be
accessed at <a href="https://www.fda.gov/media/106407/download">https://www.fda.gov/media/106407/download</a>, and the document
with updated goal dates for fiscal years 2021-2025 can be accessed at
<a href="https://www.fda.gov/media/146283/download">https://www.fda.gov/media/146283/download</a>). The OMUFA commitment letter
specifies that FDA will revise the guidance for industry and review
staff entitled ``Formal Dispute Resolution: Sponsor Appeals Above the
Division Level'' (existing FDR guidance), available at <a href="https://www.fda.gov/media/126910/download">https://www.fda.gov/media/126910/download</a>, to include circumstances and
procedures under which FDR may be used with respect to
[[Page 60106]]
Final Orders under section 505G of the FD&C Act. In addition,
consistent with the statutory requirement under section 505G(l)(4), the
OMUFA commitment letter explains that FDA will issue guidance on its
views regarding best practices for consolidated proceedings for
appeals.
For administrative efficiency, rather than amend the existing FDR
guidance to include FDR procedures for Final Orders and issue a
separate guidance for consolidated proceedings for appeals, FDA is
issuing this single guidance. This guidance addresses the process for
resolving scientific and/or medical disputes of Final Orders, including
FDR, administrative hearings, and consolidated proceedings. FDA has
incorporated recommendations from the existing FDR guidance as
appropriate.
This guidance finalizes the draft guidance entitled ``Formal
Dispute Resolution and Administrative Hearings of Final Administrative
Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act''
issued on June 23, 2023 (88 FR 41107). FDA considered comments received
on the draft guidance as the guidance was finalized. Changes from the
draft guidance to the final guidance include: (1) clarifying that the
recommendations in this guidance are limited to FDR in accordance with
section 505G(b)(2)(A)(iv)(III) and 505G(b)(4)(D)(iii) of the FD&C Act
and to hearings in accordance with section 505G(b)(3) of the FD&C Act,
and (2) removing language implying that new information could be
submitted outside of, but at the same time or during, the FDR to avoid
any suggestion that an eligible requestor or sponsor submitting a
request for FDR should actively engage with other entities within FDA
or pursue other regulatory or legal pathways on the same matter at the
same time.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Formal Dispute Resolution and
Administrative Hearings of Final Administrative Orders Under Section
505G of the Federal Food, Drug, and Cosmetic Act.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. FDA considered
the applicability of Executive Order 14192, per Office of Management
and Budget (OMB) guidance in M-25-20, and finds this action to be
deregulatory in nature.
II. Paperwork Reduction Act of 1995
Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act
of 1995 (PRA) does not apply to collections of information made under
section 505G of the FD&C Act. The information collections made in this
guidance implement the provisions of the following subsections of 505G:
(1) Section 505G(l)(4), which requires FDA to issue guidance that
specifies the consolidated proceedings for appeal and the procedures
for such proceedings where appropriate;
(2) Section 505G(b)(2)(A)(iv)(III), which requires that FDA afford
requesters of drugs that will be subject to final administrative orders
the opportunity for FDR up to the level of the Director of CDER;
(3) Section 505G(b)(3) and section 505G(b)(4)(E), which allow
persons who participated in each stage of FDR with respect to a drug to
request a hearing concerning a final administrative order with respect
to such drug. Under section 505G(b)(3)(C)(ii), a single hearing may be
conducted if more than one request is submitted with respect to the
same administrative order; and
(4) Section 505G(j), which requires that all submissions be in
electronic format.
Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-3521) is
not required for these collections of information.
In addition, this guidance refers to previously approved FDA
collections of information. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information for over-the-counter (OTC) monograph products, OTC
monograph order requests, and the OTC Monograph User Fee Program have
been approved under OMB control number 0910-0340. The collections of
information for FDR have been approved under OMB control number 0910-
0001. The collections of information in 21 CFR 10.65 relating to
meetings and correspondence have been approved under OMB control number
0910-0191.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-23707 Filed 12-22-25; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on December 23, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.